Value through Innovation27 July 2016

Clinical Study Results

  • Crobenetine - Healthy
    Clinical Study Number 599.1
    Study Indication Healthy
    Product Crobenetine
    Generic Name Crobenetine
    Lab Code
    Clinical Phase I
    Study Title

    A single-blind, placebo-controlled, parallel group, single increasing dose tolerance study in healthy male volunteers after intravenous administration of Bill 890 CL (dosage: 0.5 mg/h- 80 mglh), infusion time 1 hour.

    Study Document Trial synopsis 599.1_CO english
  • Crobenetine - Healthy
    Clinical Study Number 599.11
    Study Indication Healthy
    Product Crobenetine
    Generic Name Crobenetine
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics of 50 mg desipramine daily, given orally over 7 days with and without concomitant administration of 175 mg crobenetine, given as a 6 hrs i.v. infusion (one hour loading dose directly followed by a five hours maintenance dose). A randomised, placebo controlled, single blind (for crobenetine), two-way cross over trial in healthy male subjects.

    Study Document Trial synopsis 599.11_CO english
  • Crobenetine - Healthy
    Clinical Study Number 599.12
    Study Indication Healthy
    Product Crobenetine
    Generic Name Crobenetine
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics of 7.5 mg midazolam, given orally with and without concomitant administration of 175 mg crobenetine, given as a 6 hrs i.v. infusion (one hour loading dose directly followed by a five hours maintenance dose). A randomised, single blind, two-way crossover trial in healthy male subjects.

    Study Document Trial synopsis 599.12_CO english
  • Crobenetine - Healthy
    Clinical Study Number 599.2
    Study Indication Healthy
    Product Crobenetine
    Generic Name Crobenetine
    Lab Code
    Clinical Phase I
    Study Title

    A single blind, placebo-controlled, parallel-group, single increasing dose tolerance study in healthy young male volunteers after intravenous administration of Bill 890 CL as loading dose (dosage: 12.5, 25 and50 mg/h, infusion time 1 hour; 50 mg/h, infusion time 2 hours) followed by maintenance dose (dosage: 6.25, 12.5 and 25 mg/h, infusion time5 hours; 30 mg/h, infusion time 4 hours) and in healthy elderly male and female volunteers after intravenous administration of Bill 890 CL as loading dose (dosage: 50 mg/h, infusion time 1 hour) followed by maintenance dose (dosage: 25 mg/h, infusion time 5 hours).

    Study Document Trial synopsis 599.2_CO english
  • Crobenetine - Stroke
    Clinical Study Number 599.3
    Study Indication Stroke
    Product Crobenetine
    Generic Name Crobenetine
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, double-blind, placebo-controlled, clinical trial to evaluate the safety and tolerability in 108 patients (18 per dose group) with acute ischemic stroke after intravenous administration from 6 to 72 hours of BIII 890, as loading dose followed by maintenance dose, in escalating dose panels from 87.5 mg up to 1495 mg (total dose)

    Study Document Trial synopsis 599.3_CO english

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.